Archived Content
Monday, November 5
6:00 - 9:00 pm DINNER SHORT COURSE*
Systems for Evidence Creation and Evidence Dossiers for Payers
Randy H. Goodman, Ph.D., Manager, Pricing and Reimbursement Practice, Scientia Advisors
Grant Bagley, M.D., J.D., HillCo Partners
This course is designed to provide participants an overview of the topic of effective evidence generation, dossier production, targeted evidence materials, evidence submission and dissemination to key stakeholders for successful product commercialization in North America.
The presentation will convene basic concepts and fundamental understanding of the key terminology and issues involved in evidence review, market access, product pricing, and coverage policy decisions as well as the emerging principles of demonstrating high medical-value and clinical comparative effectiveness.
Areas to be discussed will include the various methods and tools to document unique product value(s); role of the patient stratification (e.g., differential clinical benefit, sub-classification, pharmacogenomics, etc.) and the attributes of evidence platforms that can assist with coverage and payment decisions.
Finally, in the context of health care and payment reform a review of the wider policy issues will be addressed.
Tuesday, November 6
6:00 - 9:00 pm DINNER SHORT COURSE*
Reimbursement of Cancer Genomic Analysis
Jerry Conway, Vice President, Reimbursement and Payer Strategy, Foundation Medicine, Inc.
David Parker, PH.D., Vice President, Consulting, Boston Healthcare Associates
Genomic analysis of cancer has been established as an integral part of cancer patient management as well as of cancer clinical trials. The volume of this category of molecular testing is growing and more and more laboratories include it in the “test menu” and/or “services provided”. Hereby, the issue of reimbursement of clinical genotyping of cancers is at utmost importance for laboratories and molecular diagnostic companies. The situation is complicated by the fact that pharmaceutical companies working in the field of personalized oncology possess vested interest in these matters because many of the tests are falling in the category of companion diagnostics. The landscape of the diagnostics reimbursement in the health care industry is changing dramatically, as the usual mixed bag of payers is being compressed now by the reimbursement decisions of the number one customer : The US Govermnent.
High value diagnostic tests that carry expensive price tags are under the radar of payers as potential waste or major drivers of cost savings and superior outcomes. The reimbursement decisions in this country are going to be gradually shifting from well defined or arbitrary codes to more analytical categories based on the clinical utility the tests bring to the system. Traditionally, Diagnostics and Pharmaceutical companies have not been used to this type of payment criteria, and therefore might not be fully prepared to successfully navigate this new turbulent waters.
In this workshop we will present , analyze and discuss the following points .
- Overall situation of the reimbursement landscape today
- Coding, Coverage, Policies and payment fees for cancer genomic tests
- The Medicare /CMS new view of the value of new tests
- The view from large Insurance payers
- How to generate cost effectiveness data that payers will buy into
- How to generate clinical utility data that payers will endorse
- Case studies in Pathology, Molecular Diagnostics, Proteomics, Gene Expression, Nest Gen Sequencing.
* Separate registration required